High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
NCT01655836 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-09-11
Summary
The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the radiation treatment will be given over a 3 week period using stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves the delivery of very high individual doses of radiation to tumors with high precision. This allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose of this study is to determine the safety of brachytherapy when combined with hypofractionated SBRT.
Conditions
- Prostate Cancer
- Adenocarcinoma of the Prostate
- Recurrent Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIB Prostate Cancer
Interventions
- RADIATION
-
Brachytherapy
Undergo high dose rate brachytherapy
- RADIATION
-
Stereotactic Body Radiation Therapy
Undergo stereotactic body radiation therapy
- PROCEDURE
-
Quality-of-life assessment
Ancillary studies
- OTHER
-
Questionnaire administration
Ancillary studies
Sponsors & Collaborators
-
Sidney Kimmel Cancer Center at Thomas Jefferson University
lead OTHER
Principal Investigators
-
Robert Den, MD · Thomas Jefferson University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-04
- Primary Completion
- 2016-07-27
- Completion
- 2040-01-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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